Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977179
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-07-28
Brief Title:
Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Diet Intervention Study To Mitigate Fatigue Symptoms And To Improve Muscle And Physical Function In Older Adults With Post-Acute COVID-19 Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Long-COVIDiet
Brief Summary:
The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole-Diet Approach when following a healthy US-style diet rich in anti-inflammatory properties The study will focus on evaluating its impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection PACS in adults aged 50 years and older
The main research questions this study aims to answer are
1 Does adhering to a healthy US-style diet which is abundant in anti-inflammatory properties effectively mitigate fatigue symptoms in adults with PACS
2 Does adhering to a healthy US-style diet which is abundant in anti-inflammatory properties effectively mitigate declines in muscle function and physical performance in adults with PACS
At the beginning of the study eligible participants will be randomly assigned to either the Dietary Intervention Group where they will receive personalized dietary plans and weekly sessions or the Attention Control Group where they will attend general health sessions on a weekly basis as well
This research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults By comparing the outcomes of the two groups we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS
The main research questions this study aims to answer are
1 Does adhering to a healthy US-style diet which is abundant in anti-inflammatory properties effectively mitigate fatigue symptoms in adults with PACS
2 Does adhering to a healthy US-style diet which is abundant in anti-inflammatory properties effectively mitigate declines in muscle function and physical performance in adults with PACS
At the beginning of the study eligible participants will be randomly assigned to either the Dietary Intervention Group where they will receive personalized dietary plans and weekly sessions or the Attention Control Group where they will attend general health sessions on a weekly basis as well
This research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults By comparing the outcomes of the two groups we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS
Detailed Description:
The main objective of this research is to evaluate the impact of the Whole-Diet Approach through a 16-week randomized-controlled dietary intervention on reducing symptoms of PACS Post-Acute Sequelae of SARS-CoV-2 Infection specifically targeting fatigue and muscle weakness
The study will include 56 men and women aged 50 years or older all diagnosed with PACS These participants will be randomly assigned to one of the two groups
1 Dietary Intervention Group Participants in this group will benefit from a personalized dietary plan created by a skilled Registered Dietitian RD The dietary recommendations will align with the US Healthy diet style as outlined by the Dietary Guidelines for Americans 2020-2025 Weekly group sessions with the RDPrincipal Investigator PI will facilitate the practical application of the personalized diet The RD will also focus on promoting the intake of foods with high anti-inflammatory activities
2 Attention Control Group Participants in this group will attend educational sessions on general health topics such as healthy aging eg oral health hearing loss eyesight and safety environment eg gas leaks fire fall hazards However they will not receive any specific dietary information
Throughout the 16-week intervention period all participants will be required to strictly adhere to their prescribed dietary plan and attend the designated sessions
The studys primary objectives are as follows
Aim 1 Evaluate the effect of the Whole-Diet Approach on the participants Healthy Eating Index and fatigue levels in comparison to the attention control group among adults with PACS
Aim 2 Assess the impact of the dietary intervention on muscle mass strength and physical function in adults with PACS and compare these outcomes with the attention control group
By addressing these key aims this research will provide valuable insights into the effectiveness of the Whole-Diet Approach as a potential intervention for alleviating symptoms related to PACS and enhancing overall well-being among older adults
The study will include 56 men and women aged 50 years or older all diagnosed with PACS These participants will be randomly assigned to one of the two groups
1 Dietary Intervention Group Participants in this group will benefit from a personalized dietary plan created by a skilled Registered Dietitian RD The dietary recommendations will align with the US Healthy diet style as outlined by the Dietary Guidelines for Americans 2020-2025 Weekly group sessions with the RDPrincipal Investigator PI will facilitate the practical application of the personalized diet The RD will also focus on promoting the intake of foods with high anti-inflammatory activities
2 Attention Control Group Participants in this group will attend educational sessions on general health topics such as healthy aging eg oral health hearing loss eyesight and safety environment eg gas leaks fire fall hazards However they will not receive any specific dietary information
Throughout the 16-week intervention period all participants will be required to strictly adhere to their prescribed dietary plan and attend the designated sessions
The studys primary objectives are as follows
Aim 1 Evaluate the effect of the Whole-Diet Approach on the participants Healthy Eating Index and fatigue levels in comparison to the attention control group among adults with PACS
Aim 2 Assess the impact of the dietary intervention on muscle mass strength and physical function in adults with PACS and compare these outcomes with the attention control group
By addressing these key aims this research will provide valuable insights into the effectiveness of the Whole-Diet Approach as a potential intervention for alleviating symptoms related to PACS and enhancing overall well-being among older adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None